Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica

Overview

A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life

Full Title of Study: “Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2, 2018

Detailed Description

This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period

Interventions

  • Drug: Herbal medicine
    • Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
  • Procedure: Chuna manipulation
    • Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician’s discretion.
  • Procedure: Bee venom pharmacopuncture
    • Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician’s discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
  • Procedure: Pharmacopuncture
    • Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
  • Procedure: Acupuncture
    • Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
  • Procedure: Electroacupuncture
    • Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
  • Procedure: Cupping
    • Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
  • Other: Other intervention(s)
    • Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.

Arms, Groups and Cohorts

  • Lumbar stenosis group
    • Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Numeric rating scale (NRS) of low back pain
    • Time Frame: Change from baseline to 3 months
    • Change in low back pain intensity
  • Change in Numeric rating scale (NRS) of radiating leg pain
    • Time Frame: Change from baseline to 3 months
    • Change in radiating leg pain intensity

Secondary Measures

  • Numeric rating scale (NRS) of low back pain
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Low back pain intensity for the past 3 days
  • Numeric rating scale (NRS) of radiating leg pain
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Radiating leg pain intensity for the past 3 days
  • Oswestry Disability Index (ODI)
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Functional disability questionnaire
  • EuroQol 5-dimensions 5-levels (EQ-5D-5L)
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Health-related quality of life questionnaire
  • Patient Global Impression of Change (PGIC)
    • Time Frame: 6, 12 months
    • Global patient-reported outcome
  • Current medical service use
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Current use of medical services (type, frequency, period)
  • Pain-free walking time
    • Time Frame: Baseline, 1, 2, 3, 6, 12 months
    • Average pain-free walking time for the past 3 days
  • Physical examination
    • Time Frame: Baseline, 1, 2, 3 months
    • Lumbar physical examination

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4) – Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI – Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position) – Patients who have received surgery recommendation for lumbar spinal stenosis – Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 months – Patients who have agreed to study participation Exclusion Criteria:

  • Patients with vascular claudication – Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation – Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis) – Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment) – Pregnant patients or patients planning pregnancy – Patients with serious psychological disorders – Patients unable to fill out study participation consent form – Subjects deemed unsuitable for study participation as assessed by the researchers

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jaseng Medical Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jinho Lee, Medical management director – Jaseng Medical Foundation
  • Overall Official(s)
    • Jinho Lee, KMD, Ph.D., Principal Investigator, Jaseng Medical Foundation

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